Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical
company, announced financial results for the first quarter ended
March 31, 2022. Unless otherwise stated, all comparisons are for
the first quarter of 2022 compared to the first quarter of
2021.
Product revenue, net consists entirely of revenue from sales of
NERLYNX®, Puma’s first commercial product. Product revenue, net in
the first quarter of 2022 was $40.7 million, compared to product
revenue, net of $45.8 million in the first quarter of 2021.
Based on accounting principles generally accepted in the United
States (GAAP), Puma reported net loss of $3.4 million, or $0.08 per
basic and diluted share, for the first quarter of 2022, compared to
net income of $16.5 million, or $0.41 per basic share and $0.40 per
diluted share, for the first quarter of 2021.
Non-GAAP adjusted net loss was $0.3 million, or $0.01 per basic
and diluted share, for the first quarter of 2022, compared to
non-GAAP adjusted net income of $22.4 million, or $0.56 per basic
share and $0.55 per diluted share, for the first quarter of 2021.
Non-GAAP adjusted net income excludes stock-based compensation
expense. For a reconciliation of GAAP net income (loss) to non-GAAP
adjusted net income (loss) and GAAP net income (loss) per share to
non-GAAP adjusted net income (loss) per share, please see the
financial tables at the end of this news release.
Net cash used in operating activities for the first quarter of
2022 was $26.9 million, compared to $15.7 million provided by
operating activities in the first quarter of 2021. At March 31,
2022, Puma had cash, cash equivalents and marketable securities of
$73.9 million, compared to cash, cash equivalents and marketable
securities of $82.1 million at December 31, 2021.
“2021 was an important year for Puma as we made operational
changes to maximize the efficiency of the Puma team and the
environment with which we operate,” said Alan H. Auerbach,
Chairman, Chief Executive Officer and President of Puma. “We remain
committed to increasing awareness of and access to NERLYNX as an
option to reduce the risk of recurrence for patients battling
HER2-positive breast cancer; the inclusion of NERLYNX in the
updated NCCN guidelines is an important step to expanding the
awareness and utilization of neratinib for high-risk patients.”
Mr. Auerbach added, “We anticipate the following key milestones
over the next 12 months: (i) reporting Phase II data from the
cohort of patients in the SUMMIT basket trial of neratinib in
HER2-mutated HR-positive breast cancer (H1 2022); (ii) reporting
Phase II data from the cohort of patients in the SUMMIT basket
trial of neratinib in HER2-mutated biliary tract cancer (H1 2022);
(iii) reporting Phase II data from the cohort of patients in the
SUMMIT basket trial of neratinib in non-small cell lung cancer
patients with EGFR exon 18 mutations (H2 2022); (iv) conducting a
pre-NDA meeting with the FDA to discuss the potential for an
accelerated approval pathway of neratinib in HER2-mutated
HR-positive breast cancer (H2 2022); (v) conducting a meeting with
the FDA to discuss the potential for an accelerated approval
pathway for neratinib in non-small cell lung cancer patients with
EGFR exon 18 mutations who have previously been treated with an
EGFR tyrosine kinase inhibitor (2022); (vi) reporting Phase II
TBCRC-022 trial data from Cohort 4B and 4C of the combination of
Kadcyla® plus neratinib in patients with HER2-positive breast
cancer with brain metastases who have previously been treated with
Kadcyla (H2 2022); and (vii) reporting Phase II data from the
SUMMIT trial of neratinib in cervical cancer patients with HER2
mutations (H2 2022).”
Revenue
Total revenue consists of product revenue, net from sales of
NERLYNX, Puma’s first commercial product, license revenue from
Puma’s sub-licensees and royalty revenue. For the first quarter
ended March 31, 2022, total revenue was $45.7 million, of which
$40.7 million was net product revenue and $5.0 million was royalty
revenue. This compares to total revenue of $98.2 million in the
first quarter of 2021, of which $45.8 million was net product
revenue, $50.0 million was license revenue and $2.4 million was
royalty revenue.
Operating Costs and Expenses
Total operating costs and expenses were $46.4 million for the
first quarter of 2022, compared to $78.0 million for the first
quarter of 2021.
Cost of Sales
Cost of sales was $10.8 million for the first quarter of 2022,
compared to $29.6 million for the first quarter of 2021. Cost of
sales in the first quarter of 2021 included $20.0 million for a
termination fee paid to a former sub-licensee for the return of
commercial rights to NERLYNX in Greater China, partially offset by
higher royalties due on increased non-U.S partner sales.
Selling, General and Administrative Expenses
Selling, general and administrative expenses were $20.4 million
for the first quarter of 2022, compared to $28.2 million for the
first quarter of 2021. The $7.8 million decrease resulted primarily
from decreases of approximately $3.1 million in professional fees
and expenses, primarily related to a decrease in consulting costs
for marketing and commercialization support; $2.9 million in
payroll and related costs due to reduced headcount; and $1.4
million in stock-based compensation also due to reduced
headcount.
Research and Development Expenses
Research and development expenses were $15.2 million for the
first quarter of 2022, compared to $20.2 million for the first
quarter of 2021. The $5.0 million decrease resulted primarily from
decreases of $2.5 million in internal R&D costs related
primarily to reduced payroll costs; $1.3 million in stock-based
compensation due to the impact of headcount reductions in 2021;
$0.7 million in consultants and contractors due to the close of the
CONTROL study and the winding down of the SUMMIT study; and $0.5
million in clinical trial expenses due to reduced study costs as
noted above.
Total Other Income (Expenses)
Total other expenses were $2.7 million for the first quarter of
2022, compared to total other expenses of $3.7 million for the
first quarter of 2021. The $1.0 million decrease in other expenses
resulted primarily from lower interest expense on the milestone
installment payments to Pfizer as well as lower costs related to
our outstanding debt.
Conference Call
Puma Biotechnology will host a conference call to report its
first quarter 2022 financial results and provide an update on the
Company’s business and outlook at 1:30 p.m. PDT/4:30 p.m. EDT on
Thursday, May 5, 2022. The call may be accessed by dialing (866)
682-6100 (domestic) or (862) 298-0702 (international). Please dial
in at least 10 minutes in advance and inform the operator that you
would like to join the “Puma Biotechnology Conference Call.” A live
webcast of the conference call and presentation slides may be
accessed on the Investors section of the Puma Biotechnology website
at https://www.pumabiotechnology.com. A replay of the call will be
available approximately one hour after completion of the call and
will be archived on Puma’s website for 90 days.
About Puma Biotechnology
Puma Biotechnology, Inc. is a biopharmaceutical company with a
focus on the development and commercialization of innovative
products to enhance cancer care. Puma in-licenses the global
development and commercialization rights to PB272 (neratinib,
oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral
was approved by the U.S. Food and Drug Administration in 2017 for
the extended adjuvant treatment of adult patients with early stage
HER2-overexpressed/amplified breast cancer, following adjuvant
trastuzumab-based therapy, and is marketed in the United States as
NERLYNX® (neratinib) tablets. In February 2020, NERLYNX was also
approved by the FDA in combination with capecitabine for the
treatment of adult patients with advanced or metastatic
HER2-positive breast cancer who have received two or more prior
anti-HER2-based regimens in the metastatic setting. NERLYNX was
granted marketing authorization by the European Commission in 2018
for the extended adjuvant treatment of adult patients with early
stage hormone receptor-positive HER2-overexpressed/amplified breast
cancer and who are less than one year from completion of prior
adjuvant trastuzumab-based therapy. NERLYNX is a registered
trademark of Puma Biotechnology, Inc.
Further information about Puma Biotechnology can be found at
www.pumabiotechnology.com.
Important Safety Information Regarding NERLYNX® (neratinib)
U.S. Indication
NERLYNX® (neratinib) tablets, for oral use
INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor
indicated:
- As a single agent, for the extended adjuvant treatment of adult
patients with early stage HER2-positive breast cancer, to follow
adjuvant trastuzumab-based therapy.
- In combination with capecitabine, for the treatment of adult
patients with advanced or metastatic HER2-positive breast cancer,
who have received two or more prior anti-HER2 based regimens in the
metastatic setting.
CONTRAINDICATIONS: None
WARNINGS AND PRECAUTIONS:
- Diarrhea: Manage diarrhea through either NERLYNX dose
escalation or loperamide prophylaxis. If diarrhea occurs despite
recommended prophylaxis, treat with additional antidiarrheals,
fluids, and electrolytes as clinically indicated. Withhold NERLYNX
in patients experiencing severe and/or persistent diarrhea.
Permanently discontinue NERLYNX in patients experiencing Grade 4
diarrhea or Grade ≥ 2 diarrhea that occurs after maximal dose
reduction.
- Hepatotoxicity: Monitor liver function tests monthly for the
first 3 months of treatment, then every 3 months while on treatment
and as clinically indicated. Withhold NERLYNX in patients
experiencing Grade 3 liver abnormalities and permanently
discontinue NERLYNX in patients experiencing Grade 4 liver
abnormalities.
- Embryo-Fetal Toxicity: NERLYNX can cause fetal harm. Advise
patients of potential risk to a fetus and to use effective
contraception.
ADVERSE REACTIONS:
The most common adverse reactions (reported in ≥ 5% of patients)
were as follows:
- NERLYNX as a single agent: Diarrhea, nausea, abdominal pain,
fatigue, vomiting, rash, stomatitis, decreased appetite, muscle
spasms, dyspepsia, AST or ALT increased, nail disorder, dry skin,
abdominal distention, epistaxis, weight decreased, and urinary
tract infection.
- NERLYNX in combination with capecitabine: Diarrhea, nausea,
vomiting, decreased appetite, constipation, fatigue/asthenia,
weight decreased, dizziness, back pain, arthralgia, urinary tract
infection, upper respiratory tract infection, abdominal distention,
renal impairment, and muscle spasms.
To report SUSPECTED ADVERSE REACTIONS, contact Puma
Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) or FDA at
1-800-FDA-1088 or https://www.fda.gov/medwatch.
DRUG INTERACTIONS:
- Gastric acid reducing agents: Avoid concomitant use with proton
pump inhibitors. Separate NERLYNX by at least 3 hours with
antacids. Separate NERLYNX by at least 2 hours before or 10 hours
after H2-receptor antagonists. Or separate NERLYNX by at least 3
hours with antacids.
- Strong CYP3A4 inhibitors: Avoid concomitant use.
- P-gp and moderate CYP3A4 dual inhibitors: Avoid concomitant
use.
- Strong or moderate CYP3A4 inducers: Avoid concomitant use.
- Certain P-gp substrates: Monitor for adverse reactions of P-gp
substrates for which minimal concentration change may lead to
serious adverse reactions when used concomitantly with
NERLYNX.
USE IN SPECIFIC POPULATIONS:
- Lactation: Advise women not to breastfeed.
Please see Full Prescribing Information for additional safety
information.
To help ensure patients have access to NERLYNX, Puma has
implemented the Puma Patient Lynx support program to assist
patients and healthcare providers with reimbursement support and
referrals to resources that can help with financial assistance.
More information on the Puma Patient Lynx program can be found at
https://www.NERLYNX.com or 1-855-816-5421.
Forward-Looking Statements
This press release contains forward-looking statements,
including statements regarding Puma’s anticipated milestones. All
forward-looking statements involve risks and uncertainties that
could cause Puma’s actual results to differ materially from the
anticipated results and expectations expressed in these
forward-looking statements. These statements are based on current
expectations, forecasts and assumptions, and actual outcomes and
results could differ materially from these statements due to a
number of factors, which include, but are not limited to, any
adverse impact on Puma’s business or the global economy and
financial markets, generally, from the global COVID-19 pandemic and
the risk factors disclosed in the periodic and current reports
filed by Puma with the Securities and Exchange Commission from time
to time, including Puma’s Annual Report on Form 10-K for the year
ended December 31, 2021 and subsequent filings. Readers are
cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date hereof. Puma assumes no
obligation to update these forward-looking statements, except as
required by law.
PUMA BIOTECHNOLOGY, INC. AND
SUBSIDIARIES
CONSOLIDATED STATEMENTS OF
OPERATIONS
(in millions except share and
per share data)
Three Months Ended
March 31,
2022
2021
(Unaudited)
(Unaudited)
Revenues: Product revenue, net
$
40.7
$
45.8
License revenue
—
50.0
Royalty revenue
5.0
2.4
Total revenue
45.7
98.2
Operating costs and expenses: Cost of sales
10.8
29.6
Selling, general and administrative
20.4
28.2
Research and development
15.2
20.2
Total operating costs and expenses
46.4
78.0
Income (loss) from operations
(0.7
)
20.2
Other expenses: Interest expense
(2.7
)
(3.5
)
Legal verdict expense
—
(0.2
)
Total other expenses
(2.7
)
(3.7
)
Net income (loss) before income taxes
(3.4
)
16.5
Income tax expense
—
—
Net income (loss)
$
(3.4
)
$
16.5
Net income (loss) per share of common stock—basic
$
(0.08
)
$
0.41
Net income (loss) per share of common stock—diluted
$
(0.08
)
$
0.40
Weighted-average shares of common stock outstanding—basic
42,207,709
40,260,864
Weighted-average shares of common stock outstanding—diluted
42,207,709
40,894,868
PUMA BIOTECHNOLOGY, INC. AND
SUBSIDIARIES
LIQUIDITY AND CAPITAL
RESOURCES
(in millions)
March 31,
December 31,
2022
2021
(Unaudited)
Cash and cash equivalents
$
63.9
$
63.1
Marketable securities
10.0
19.0
Working capital
42.8
30.4
Stockholders' equity (deficit)
7.1
(2.4
)
Three Months
Three Months
Ended
Ended
March 31,
March 31,
2022
2021
(Unaudited)
(Unaudited)
Cash provided by (used in): Operating activities
$
(26.9
)
$
15.7
Investing activities
9.0
(5.3
)
Financing activities
9.8
—
Increase (decrease) in cash and cash equivalents, and
restricted cash
$
(8.1
)
$
10.4
Use of Non-GAAP Measures
In addition to operating results as calculated in accordance
with GAAP, Puma uses certain non-GAAP financial measures when
planning, monitoring, and evaluating operational performance. The
following table presents the Company’s net income (loss) and net
income (loss) per share calculated in accordance with GAAP and as
adjusted to remove the impact of stock-based compensation expense.
For the three months ended March 31, 2022, stock-based compensation
represented approximately 8.8% of operating expenses, and 12.1% for
the same period in 2021, in each case excluding cost of sales.
Puma’s management believes that these non-GAAP financial measures
are useful to enhance understanding of Puma’s financial
performance, are more indicative of its operational performance,
and facilitate a better comparison among fiscal periods. These
non-GAAP financial measures are not, and should not be viewed as,
substitutes for GAAP reporting measures.
PUMA BIOTECHNOLOGY, INC. AND
SUBSIDIARIES
Reconciliation of GAAP Net
Income (Loss) to Non-GAAP Adjusted Net Income (Loss) and
GAAP Net Income (Loss) Per
Share to Non-GAAP Adjusted Net Income (Loss) Per Share
(in millions except share and
per share data)
(Unaudited)
Three Months Ended March
31,
2022
2021
GAAP net income (loss)
$
(3.4
)
$
16.5
Adjustments: Stock-based compensation - Selling, general and
administrative
2.2
3.6
(1
)
Research and development
0.9
2.3
(2
)
Non-GAAP adjusted net income (loss)
$
(0.3
)
$
22.4
GAAP net income (loss) per share—basic
$
(0.08
)
$
0.41
Adjustment to net income (loss) (as detailed above)
0.07
0.15
Non-GAAP adjusted basic net income (loss) per share
$
(0.01
)
$
0.56
(3
)
GAAP net income (loss) per share—diluted
$
(0.08
)
$
0.40
Adjustment to net income (loss) (as detailed above)
0.07
0.15
Non-GAAP adjusted diluted net income (loss) per share
$
(0.01
)
(4)
$
0.55
(5
)
(1) To reflect a non-cash charge to operating expense for selling,
general, and administrative stock-based compensation. (2) To
reflect a non-cash charge to operating expense for research and
development stock-based compensation. (3) Non-GAAP adjusted basic
net income (loss) per share was calculated based on 42,207,709 and
40,260,864 weighted-average shares of common stock outstanding for
the three months ended March 31, 2022 and 2021, respectively. (4)
Potentially dilutive common stock equivalents (stock options,
restricted stock units and warrants) were not included in this
non-GAAP adjusted diluted net loss per share for the three months
ended March 31, 2022, as these shares would be considered
anti-dilutive. (5) Non-GAAP adjusted diluted net income per share
was calculated based on 40,894,868 weighted-average shares of
common stock outstanding for the three months ended March 31, 2021.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220505005245/en/
Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc.,
+1 424 248 6500 info@pumabiotechnology.com
ir@pumabiotechnology.com
David Schull, Russo Partners, +1 212 845 4200
david.schull@russopartnersllc.com
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